Hypothermia After Cardiac Arrest - Effects on Myocardial Function and Inflammatory Response.

NCT03743584 | Completed

• 1 other identifier: 2018/1057 C
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The on-going randomized clinical trial TTM2 (Target Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest, NCT02908308) investigates if there is a difference in mortality, neurological function or quality of life in comatose survivors after out-of-hospital cardiac arrest if treated (Group A) at target temperature of 33 oC or (Group B) by avoiding fever during the first 24 h. In this sub study, the effect of different target temperatures on cardiac and circulatory physiology is evaluated by echocardiography and pulmonary artery catheter. Tissue damage after cardiac arrest in part is caused by an activation of different parts of the inflammatory system (reperfusion injury). This study investigates the effect of temperature management on inflammation and the link to the circulatory effects.

Conditions

Out of Hospital Cardiac Arrest; Inflammatory Response; Ischemia Reperfusion Injury; Hypothermia

Keywords

cardiac arrest; hypothermia, therapeutic; ischemia reperfusion injury; Innate Immune system

Outcome Measures

Primary Outcomes (2)

• Change in wall motion score

  Cardiac output

  48 hours , 72 hours, 6 months

• Plasma concentration of inflammatory markers

  inflammatory markers to be specified (e.g. Complement system activation, pro-inflammatory cytokines like IL-6 expressed as nanogram/milliliter)

  48 hours , 72 hours, 6 months

Secondary Outcomes (1)

• Association between inflammatory response and cardiac function

  48 hours , 72 hours, 6 months

Study Arms (2)

Targeted temperature management at 33°C

EXPERIMENTAL

Cooling and temperature control at 33°C, according to the study protocol of the TTM2-trial

Procedure: Targeted temperature management

Standard care, early treatment of fever

ACTIVE COMPARATOR

Standard of care and normothermia. If temperature 37,8 °C or above use of device for temperature control.

Procedure: Standard care, early treatment of fever

Interventions

Targeted temperature management PROCEDURE

Target temperature management at 33°C

Targeted temperature management at 33°C

Standard care, early treatment of fever PROCEDURE

Standard of care with early treatment of fever

Standard care, early treatment of fever

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included in the TTM2-trial and treated at the Intensive Care Unit at Rikshospitalet, Oslo
• Out-of-hospital cardiac arrest of a presumed cardiac or unknown cause
• Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions.
• Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of \<4) and no verbal response to pain after sustained ROSC.
• Eligible for intensive care without restrictions or limitations

You may not qualify if:

• Not included in the TTM2-trial
• Unwitnessed cardiac arrest with an initial rhythm of asystole
• Temperature on admission \<30°C.
• On ECMO prior to ROSC
• Obvious or suspected pregnancy
• Intracranial bleeding
• Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy"

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Reperfusion Injury; Hypothermia; Heart Arrest

Interventions

Hypothermia, Induced; Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Søren Pischke, MD, PhD

  Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical team responsible for the participant (physicians, nurses and others) and involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention and as temperature is a vital sign required for clinical care. Measures will be taken to ensure that the information about allocation will not disseminate beyond the immediate group of caregivers responsible for patient care. A blinded physician will evaluate the patient for Cardiac function at pre-specified time-Points after randomisation and make a statement on Cardiac function.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD. Senior consultant

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 16, 2018
• Study Start: November 8, 2018
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

NO (1)